TWI797108B - Container for medical and/or pharmaceutical products, method of manufacturing the same and use of the same - Google Patents

Abstract

The disclosure pertains to a container (100, 300) for storing medical and/or pharmaceutical products. The container includes a plastic container body (102) comprising a side wall (202), a base (204) and an opening (206) defining a storage volume (108), a flange (104) formed on the container body (102) and configured to receive a connecting element (312) of a cap (310) provided with a tamper-evident mechanism (414), and an active insert (106) placed within the container body (102). This container is an improved container for the storage of products. The disclosure also pertains to a sealed package comprising this container.

Description

Container for medical and/or pharmaceutical products, method for its manufacture and use thereof

The present invention is directed to a container for storing medical and/or pharmaceutical products and to a method of manufacturing such a container. The invention is also directed to a sealed package comprising such a container.

Document US 8,875,917 B2 describes a container which receives bulk storage products such as pills or tablets, in particular effervescent tablets. An object is to provide a closure for a container which has improved storage performance and which can be manufactured in a cost-effective manner. The closure lid comprises a lid portion connected by a hinge to a connecting element intended to be fastened to a container body. The lid portion includes a side edge joined into the opening of the container body in a moisture-proof manner and a drying chamber. The container body comprises a flange for fixedly receiving an annular connecting element of the closure cap. The ring element can be snapped onto the flange (positive fit). The lid includes a frangible tamper-evident link between the lid portion and the ring portion. When using for the first time, the user must first destroy the tamper-evident layer to open the closure cap and access the product stored in the container. Thus, if the tamper-evident link is intact, the consumer is assured that the container has not been opened.

The cover further includes a desiccant housing to receive a desiccant, such as silica gel, calcium chloride, molecular sieves, other desiccants, or any mixture thereof. These active agents allow the removal of moisture from the interior of the container body to preserve stored moisture sensitive articles. In fact, moisture comes from the external environment and can enter the interior of the container, for example, when the container is filled to store the product, but also during the storage of the product by permeation. Access to the interior of a container through penetration (diffusion) of the container wall, or through the seal between the container body and lid, or through repeated opening and closing of the container during use of the product by the consumer . Thus, a dry enclosure makes it possible to increase the shelf life and storage time of the product contained in the container.

In this context, there is a need to provide an improved container for storing medical and/or pharmaceutical products that are sensitive to moisture and/or other gaseous substances, such as oxygen or volatile organic compounds. In particular, there is a need for an improved, reliable, easily-disposable, economical container that avoids the problem of leakage of desiccant or reagents used to treat the atmosphere within the container and allows the absorption of moisture and/or gaseous substances entering the container (even in After a quick open/close cycle), a tamper-evident indicator (tamper indicator) is also provided.

Therefore, a container for packaging sensitive products such as medical and/or pharmaceutical products is proposed, as described in the technical solution. The container includes a plastic container body. The container body includes a side wall, a base and an opening to define a storage volume. The container also includes an active insert within the body of the container.

The container also includes a flange configured to receive a connecting element of a lid including a tamper evident mechanism. The lid can be hinged (hinged lid) or non-hinged. Preferably, the lid is hinged.

Also proposed is an assembly for packaging sensitive products such as medical and/or pharmaceutical products, comprising a container fitted with a lid, preferably a hinged lid, comprising a tamper-evident mechanism.

This container exhibits the safety characteristics of containers with a tamper-evident system, which safety characteristics are especially important in the industry of containers for storing medical and/or pharmaceutical products. In this context, the presence of an active insert installed in the container body allows the use of a smaller and lighter hinged lid while ensuring Preserve the best effect of products on the environment. The container can be compatible with existing filling and assembly lines used to package sensitive articles in a container and require little or no modification of the packaging of sensitive articles or the assembly of the lid on the container body. Compared to existing hinged lids that include a dehumidification chamber, the assembly of the container and hinged lid according to the invention limits obstruction of the access opening to the contents of the container and the lid is less likely to fall under its gravity onto the container body.

An unclosed container may be provided without the need to open the lid prior to filling the container and a preliminary stage of packaging the product into the storage volume within the container. Furthermore, the container may include a tamper-evident mechanism (tamper indicator of the container).

The container may further include a lid fitted to the container body. The lid is preferably hinged, ie it is connected to the container body via a hinge. The container body and lid are configured to form an air-tight and moisture-tight seal between the container body and the lid.

The container may further include medical and/or pharmaceutical products stored in the storage volume. The container and/or hinged lid can be configured to allow dispensing of the product.

The active insert comprises an active material capable of acting on the atmosphere of the storage volume of the container. In other words, the active material is able to act on the gaseous species present in the storage volume of the container. The role may notably maintain the quality of sensitive articles during their storage by protecting them from gaseous substances that could impair their integrity and/or their properties, e.g. by maintaining the physical and/or as long as possible and/or as long as possible or chemical integrity. The active insert is preferably formed from a material comprising a polymer and at least one active agent capable of trapping and/or releasing one or more gaseous species such as, for example, moisture, oxygen and/or a volatile organic compound.

Medical and/or pharmaceutical products may include any product that has a medical and/or pharmaceutical function. This may include products such as test strips, pharmaceuticals, dietary supplements, pills, tablets, capsules, granules and powders. The container and/or lid (preferably hinged) can be configured to meet this requirement when the container is closed by the lid. Air tightness and protection requirements for medical and/or medicinal functions. Likewise, the plastic material of the container body can be compatible with this medical and/or pharmaceutical function.

The container body can be of any shape. The container body may have a generally tubular shape. A tubular shape means the shape of a cylinder having a circular or non-circular base. For example, the substrate can be a disc, an oval, a square, a rectangle, a regular or irregular polygon, or a combination of planar and/or curved surfaces. Furthermore, the diameter and/or thickness of the tubular wall may vary at least partially along the length of the tubular wall of the container body.

In an example, the container can further include any combination of the following features:

- The container body may have a generally tubular shape.

- The container system is injection molded.

- The plastic material of the container body has a low permeability to moisture and/or oxygen, preferably to moisture. The plastic material can be selected from polyolefins (polyethylene, polypropylene), polyester, polycarbonate, cycloolefins, preferably polyolefins, in particular polypropylene and/or polyethylene.

- The active insert comprises a generally tubular side wall.

- The bottom ends of the side walls of the active insert are closed by a base.

- The active insert can be molded directly with the container body, especially by overmolding.

- Alternatively, the active insert may be molded separately from the container body and then embedded in the container body, eg by pushing the active insert into the container body or mounting the container body on the active insert.

- In the case where the active insert is molded separately from the container body and then fitted within the container body, the active insert can be formed by pressing or pressing at least a portion of its side wall to a periphery of the inner surface of the side wall of the container body Part up and hold.

- The active material comprises at least one active agent.

- The active agent is capable of interacting with substances such as moisture, oxygen, volatile organic compounds and/or odors At least one gaseous species interacts with one of the reagents. In particular, an active agent is an agent capable of trapping and/or releasing at least one gaseous substance such as moisture, oxygen, volatile organic compounds and/or odor. Preferably, the active agent is capable of trapping moisture and/or oxygen.

- The active agent is a desiccant and/or an oxygen scavenger.

- The desiccant is selected from silica gel, calcium oxide, clay, molecular sieves, zeolites, deliquescent salts such as, for example, calcium chloride, magnesium sulfate, potassium acetate, or any combination thereof.

- The oxygen scavenger is selected from iron-based oxygen scavengers, ascorbic acid, polymer-based oxygen scavengers or any combination thereof.

- The active material further comprises a polymer in which the active agent is dispersed. The polymer can be, for example, a thermosetting or thermoplastic (preferably thermoplastic) polymer.

- The polymer is preferably substantially permeable to gaseous species that interact with the active agent. The polymer can be selected based on the transmission rate of the gaseous species under consideration.

- Polymers selected from: Polyolefin based polymers such as Polyethylene, HDPE, LDPE, Polypropylene (PP), Polystyrene (PS), Polyvinyl Chloride (PVC), Ethylene Vinyl Acetate (EVA), Ethylene Vinyl acetate copolymer (EVOH), cycloolefin copolymer (COC); polyester-based polymers such as polycaprolactone (PCD), polylactic acid (PLA), polyethylene terephthalate (PET) , polybutylene terephthalate (PBT), polycarbonate (PC), polyoxymethylene (POM), polyamide, PPS vulcanized polyethylene, BOPP or cellulose.

- The flange is peripheral and forms a fastening member placed on the outer surface of the side wall of the container body. It is configured to receive a cover, more specifically, a connecting element of a cover.

- The flange is preferably continuous, ie formed over the entire circumference of one of the container bodies; in another embodiment, the flange may be discontinuous.

- The flange is positioned towards the upper end of the side wall of the container body near the opening of the container body. In other words In other words, it is placed on a portion of the side wall of the container body adjacent to the opening of the container body.

2/3 T2，較佳地，T1

1/2 T2。 - The flange has a vertically measured thickness T1 at the junction with the container body which is smaller than the horizontally measured thickness T2 of the side wall of the container body. Preferably, T1

2/3 T2, preferably T1

1/2 T2.

- The flange is reinforced by an array of ribs joining the flange to the outer surface of the side wall of the container body. These ribs serve to stiffen the flange especially when the thickness of the flange is greatly reduced.

- The flange has a horizontal portion extending from the side wall of the container body to the outside and is perpendicular to the side wall. In other words, the horizontal portion (or section) extends radially outward from the side wall of the container body.

- The flange further comprises a vertical portion extending vertically from the end of the horizontal portion of the flange. Preferably, the vertical portion (or section) extends perpendicularly to the horizontal portion. It may extend towards the opening of the container body (ie upwards when the container body rests on its base) or towards the base of the container body (downwards). Preferably, the vertical portion extends downwards.

- The horizontal portion of the flange (or collar) comprises a horizontal upper surface. This horizontal surface is used to support the connecting elements of the (preferably hinged) cover and to immobilize the cover and to fix the cover vertically on the flange, while preventing the cover from sliding or detaching from the flange, especially when (for example) When a high force is applied to the lid during the stage of fitting the lid on the container body. This configuration is superior to existing flanges having an inclined upper surface on which the connecting element of the cover will more easily slide (under a pressure) along the inclined upper surface, sometimes until passing under the flange. . Another advantage is that the axis of rotation of the hinge of the lid is fixed and well defined due to the preferably vertical holding of the lid on the flange. The precisely defined rotation of the lid during the opening and closing cycle allows positioning of the sealing member of the lid preferably tight against the container body and then allows a better sealing quality in terms of airtightness and moisture resistance.

- The horizontal upper surface of the horizontal section includes a rounded or chamfered portion at its outer end. This makes the cover easier to assemble. In fact, the assembly of the connecting element of the lid on the fastening member (or flange) of the container body is easy and effortless. Also, when the lid is not perfectly aligned with the container body on the assembly line, the radius The cover can be guided and centered about the flange during assembly of the cover.

- The flange has an angular cross-section, preferably at an angle of 90°. This angle is formed by the horizontal part and the vertical part of the flange.

- The angular shape has a rounded upper surface; in other words, the horizontal upper surface of the horizontal portion has a rounded shape at its outer end (from which the vertical section extends). Thus, the flange will have a radius between the horizontal upper surface of the horizontal portion and the outer side surface of the vertical portion. The rounded upper surface allows the lid to be fitted more easily on the flange of the container body without requiring exact alignment of the connecting element of the lid relative to the flange and without requiring great force to fasten the connecting element onto the flange.

- Angular shapes have a chamfered upper surface. In other words, the corner shape has a chamfer between the horizontal upper surface of the horizontal portion and the outer side surface of the vertical portion. The chamfered upper surface also facilitates the fitting of the connecting element of the lid onto the flange of the container body.

- An angular shape has a right angle between the horizontal upper surface of the horizontal part and the outer side surface of the vertical part.

- The thickness of the horizontal part of the flange is less than that of the vertical part.

- The thickness of the horizontal part of the flange is less than the thickness of the side wall of the container body.

- The ratio between the thickness of the horizontal portion of the flange and the thickness of the side wall of the container body in the area adjacent to the horizontal portion is less than or equal to 2/3, preferably 1/2. In other words, the thickness of the horizontal portion is at most 2/3 of the thickness of the side wall of the container body taken at its junction with the horizontal portion of the flange. This thickness especially avoids shrinkage (deformation or voiding) on the inner surface of the side wall of the container body immediately adjacent to the flange and thus ensures a well-defined inner surface in this area, even during the manufacturing process of the container body (for example, by Use short cooling cycle times during injection molding).

- The container further comprises a preferably hinged lid. The lid is molded separately from the container body and fitted to the container body via a flange. This has the particular advantage of being able to use different materials for the lid and container body and/or or color advantages.

- the lid comprises: a connecting element (preferably an annular connecting element) configured to be fixed to the flange of the container body; a lid portion configured to close the opening of the container body in an airtight manner; and A tamper-evident mechanism interposed between the cover portion and the connecting element.

- The tamper evident mechanism may be any element that allows indicating to the user that the container and its lid have never been opened. Destroy or remove the tamper-evident mechanism when opening the lid for the first time. It may consist of connecting the cover part directly to one or several frangible links (or frangible bridges) of the connecting elements. Alternatively, it may comprise a frangible strip connected to the cover portion and the connection element (eg by a breakable link between the frangible strip and the cover portion/connection element). The easy-tear strip may have an extension that facilitates gripping and removing the strip when the container is first opened. The tamper-evident mechanism gives the user a clear indication once the closure has been opened for the first time.

- The lid may be a tamper-evident closure without any hinge, which involves that when the lid is opened, the lid part is no longer attached to the container body. Caps of this type generally comprise a cap portion, an annular connecting element and a tamper-evident mechanism such as, for example, frangible links between the connecting element and the cap portion. During the first closing of the cap after filling the product into the storage volume, the ring-shaped connecting element snaps onto the flange of the container body. After opening for the first time, the lid part is completely separated from the connection element (the connection element remains on the flange of the container body).

- According to a preferred embodiment, the cover is a hinged cover (or a cover with a hinge). Such a hinged lid comprises a hinge connecting the lid part to the connecting element. In this way, the lid portion remains attached to the container body during the opening and closing cycles of the container, even after the consumer opens the lid for the first time. A hinged tamper-evident closure including an annular connecting member is described, for example, in US Patent No. 8,875,917 B2.

- the lid (preferably hinged) is configured to cooperate with the side wall of the container body to form an airtight seal seal up. This allows better protection of sensitive articles to be stored.

- The cover is made of plastic. The plastic material can be the same or different from the material of the container body. Preferably, the plastic material is different from the material of the container body. For example, the lid may advantageously be of a material that is (slightly) more flexible than the material of the container body.

- Cover is injection molded.

- The plastic material of the cover has a low permeability to moisture and/or oxygen, preferably to moisture. The plastic material can be selected from polyolefins (polyethylene, polypropylene), polyester, polycarbonate, cycloolefins, preferably polyolefins, in particular polypropylene and/or polyethylene.

- The cover can be made of a single material or two different materials. Two different materials allow combining the barrier properties of materials with different gases (for example, combining an oxygen barrier material with a moisture barrier material) or combining the barrier properties of a first material with the elastic properties of a second material (to form hinges and /or form a flexible seal).

- Cover molded as a single piece. When the lid is hinged it is preferably molded in the closed position.

- the lid portion has a sealing surface configured to cooperate with a sealing surface on the container body to form an airtight seal between the lid and the container body when the lid is in the closed position.

- The cover portion includes a sealing lip. The sealing skirt is configured to cooperate with the container body to form an airtight seal. In other words, the sealing surface of the cover part is positioned on this sealing side edge. Preferably, the sealing skirt includes a protrusion on its lower portion. The sealing skirt extends from the inside of the lid portion in a direction substantially perpendicular to the top wall of the lid portion. It preferably comprises a protrusion positioned towards the lower end of the sealing skirt (the free end of the skirt opposite the end by which the skirt is attached to the inner side of the top wall of the lid part). The projection is guided towards the side wall of the container body. Accordingly, the protrusion formed on the sealing side edge of the lid portion can constitute a sealing surface of the lid that cooperates with the side wall of the container body to form an airtight seal when the lid is in the closed position.

- Preferably, the sealing side edge of the lid part cooperating with the side wall of the container body forms the only sealing surface between the lid and the container body.

- The sealing surface of the container body is positioned on the side wall of the container body, preferably on the inner surface of the side wall of the container body. The sealing surface of the container body may be located on a flat portion of the inner surface of the side wall of the container body or may be located in a peripheral groove and/or a peripheral protrusion formed on the inner surface of the side wall of the container body.

- The sealing surface of the container body configured to cooperate with the sealing surface of the lid is located in a peripheral recess on the inner surface of the side wall of the container body.

- The radius of the peripheral recess is greater than the radius of the protrusion on the sealing side edge.

- The sealing surface of the container body is preferably not axially adjacent to the peripheral flange (not vertically aligned).

- The connecting element of the (preferably hinged) cover is configured to snap over the flange (ie form a positive joint).

- The connecting element of the lid comprises on its inner surface a groove configured to cooperate with the flange of the container body.

- The connecting element of the cover (preferably hinged) is a ring element.

- The connecting element of the lid comprises on its inner surface a vertical cylindrical surface S5 which cooperates with the outer surface S4 of the vertical part of the flange once the lid is assembled on the container body. Preferably, the diameter of the vertical cylindrical surface S5 of the connecting element is equal to or smaller (more preferably smaller) than the outer diameter of the vertical portion of the flange before the lid is assembled to the container body.

- The connecting element of the lid is made of an elastic material that allows it to extend diametrically after fitting on the container body. In this way and after fitting the lid on the container body, the connecting element of the lid exerts pressure on the flange to thereby limit the rotation of the lid around the flange of the container body, especially when opening the lid.

- The lid (preferably hinged) further comprises a tamper evident mechanism.

- The tamper evident mechanism comprises at least one frangible link, preferably a plurality of frangible links, connecting the cover part to the connecting element.

- The tamper-evident mechanism includes a tear strip connecting the lid part to the connecting element.

- Destroying the tamper-evident mechanism when opening the cap for the first time.

- The lid (preferably hinged) does not include a drying chamber and/or an active agent.

- The lid (preferably hinged) comprises an opening member with a grip and/or a recess in the lid part.

- The lid (preferably hinged) has an overall height of less than 15mm, preferably less than 12mm.

- The lid (preferably hinged) has a total weight of less than 3g.

- When the lid closes the opening of the container body, the container has a concentration of less than 1 mg/day, preferably less than 0.7 mg/day, more preferably The moisture vapor permeability W is less than 0.5mg/day.

- The degree of moisture penetration depends inter alia on the length of the seal between the lid and the container body. When the lid closes the opening of the container body, the container has a moisture vapor permeability of less than 10 μg/day/mm sealing length, preferably less than 7 μg/day/mm sealing surface length at 40°C and 75% relative humidity (rH) W. In other words, for a circular container with a seal of 25 mm diameter, the container has a moisture vapor transmission rate of less than 785 μg/day at 40° C. and 75% rH.

- Moisture vapor permeability also depends on container size and materials of construction. Considerations: ○ "W" is the moisture vapor permeability of a container blocked by its lid and set according to standard method ASTM D7709-12 at 40°C, 75% rH, ○"S" is the sum of the containers in ^m2 External area, ○ "e" is the average thickness of the container in mm, and the moisture permeability P=We/S of the container closed by its lid is less than 220mg.mm/m ² at 40°C and 75% rH. day, preferably less than 160 mg.mm/m ² .day, preferably less than 120 mg.mm/m ² .day.

The invention also relates to a sealed package comprising at least one container according to the invention, wherein the sealed package is substantially airtight, preferably impermeable to moisture and/or oxygen. At least one container (preferably at least two containers) is sealed within the package and is open (eg, without a lid). The sealed package can be, for example, a sealed aluminum bag. In fact, the container can be set open before it is filled with the medical and/or pharmaceutical product. One or several containers can be stored and/or shipped in one and the same sealed package. In this way, the absorption properties of the active agent can be preserved until the container is filled with a medical and/or pharmaceutical product and then closed with a cap.

The packaging is preferably made of a flexible material that is substantially impermeable to moisture.

Preferably, the package is made of a material having a moisture vapor transmission rate of less than 3 g/m ² /24 hrs, more preferably less than 0.3 g/m ² /24 hrs measured according to standard method ASTM E963 at 8°C and 90% RH production. Examples of materials are film materials comprising at least one layer of polymer and/or aluminum. The polymer is preferably selected from polyolefins and polyesters. More preferably, the material of the packaging has a moisture vapor transmission rate of less than 0.1 g/m ² /day at 38°C, 90% RH.

The packaging is preferably hermetically sealed. For example, if the package is an aluminum bag, it can be sealed by applying heat and/or pressure, optionally using a sealant or an adhesive layer.

The sealed package may further contain an active agent capable of interacting with one or more gaseous species of moisture, oxygen and/or volatile organic compounds. The active agent is capable of trapping moisture and/or oxygen. Alternatively, the active agent is capable of releasing moisture. The active agent may be contained in a can or packet. Alternatively, it may be integrated in a molded article made of a composition comprising the active agent and at least one polymer, such as a thermosetting polymer or a thermoplastic polymer. Next, the active agent Cans, packets and/or molded articles may be included in the packaging.

The sealed package may further contain a substance capable of releasing moisture within the sealed package, preferably a substance capable of releasing a given amount of moisture within the sealed package. Once the substance is placed in the package, it is capable of releasing moisture. An advantage of combining the container of the present invention with a moisture releasing substance in a sealed package is that during storage of the container of the present invention, the substance hydrates the active insert of the container until an equilibrium is reached within the package. It may be advantageous when the container is intended to store medical and/or pharmaceutical products that need to be stored in an environment that is not completely dry or where the relative humidity is maintained at a certain level, such as, for example, gelatin-coated capsules. This optimum level of relative humidity for preserving sensitive products depends on the medical and/or pharmaceutical products and can be between 2% rH and 80% rH, preferably between 5% rH and 60% Between rH. As an example of application, depending on the active material of the active insert and its level of hydration, the active insert can equilibrate the storage volume and its contents at a substantially constant relative humidity once the container is filled with sensitive products and closed. Inclusions (sensitive articles), this level of relative humidity is between the water activity of the active insert (hydrated at a specific level) and the water activity of the sensitive article expressed as a percentage.

More preferably, the substance is capable of equilibrating the relative humidity within the package at a substantially constant level of at least 2% rH at 20°C, more preferably at least 5% rH at 20°C.

The substance may be water, eg a given amount of water. The substance can also be a saturated saline solution. A desired relative humidity within the package can be achieved by selecting the appropriate salt. The substance (water or a saturated saline solution) may be contained in a liquid-impermeable and moisture-permeable enclosure such as a container or tank or a bag. This shell can then be added to the package.

Alternatively, the substance may be a hydration active agent capable of releasing moisture. Examples of such agents are silica gels, clays, deliquescent salts or mixtures thereof.

Preferably, the substance is selected from one of silica gel, bentonite, montmorillonite or any combination thereof Hydration actives. These reagents can be fully hydrated (saturated). Alternatively, these agents can be hydrated with a given amount of water. Depending on the hydration level of the reagents, the reagents are capable of equilibrating the relative humidity within the package at a substantially constant level. For example, EP 2277799 describes the hydration of such reagents at a predetermined level.

The substance may be in the form of a powder or granules. It may be contained in a can or packet that is permeable to moisture. Alternatively, the substance may be integrated in a molded article made from a composition comprising the substance and at least one polymer, such as a thermosetting polymer or a thermoplastic polymer. The molded article can be in any shape, for example a tablet, a sphere, a wafer or in the form of pellets of the compound. Then, cans, packets and/or molded articles containing moisture releasing substances may be included in the packaging.

The invention also relates to a method for manufacturing a container. The method comprises: manufacturing a container body, in particular by thermoplastic injection moulding, as described in the technical solution. The method also includes: molding an active insert, in particular by thermoplastic injection molding; and assembling the active insert within the container body.

The active insert can be assembled in the container body by any state-of-the-art assembly technique currently known, such as, for example, a clamp and friction hold, a snap, a weld or a joint.

Alternatively, the container may be obtained by overmoulding, for example, the container body may be formed by any known technique of the plastics industry, such as molding over an insert, double injection, co-moulding, two-component injection. Overmolded around a pre-injected active insert, or vice versa.

The invention also relates to the use of such a container for storing and/or packaging medical and/or pharmaceutical products. In sensitive articles, for example pharmaceuticals such as effervescent or non-effervescent tablets, capsules, granules, powders, health foods such as vitamins or minerals, and diagnostic strips may be included.

The invention also relates to a method of filling such a container with a medical and/or pharmaceutical product. The method comprises: - supplying a container comprising an active insert in a container body provided with a flange - the flange is configured to receive a connecting element of a lid (preferably hinged); - fill the container body with medical and/or pharmaceutical products; and - will have one of a tamper-evident mechanism A lid (preferably hinged) is fitted to the container body, preferably by applying a vertical pressure to the lid.

Assembly is achieved by fastening the connecting element of the lid to the flange of the container body.

The method does not require a stage of opening the lid prior to filling the container body with the product. In fact, the container may be provided open, ie without a lid.

The container body can be conveyed on a conventional filling line designed to fasten a lid on the container body: after having filled the product in the container body equipped with its active insert, the container body is conveyed to an assembly station , wherein a cap supply line places the cap on the opening of the container body and wherein a vertical pressure is applied to snap and secure the cap to the flange of the container body.

Another object of the present invention relates to a container for packaging medical and/or pharmaceutical products, wherein the container comprises: - a plastic container body comprising side walls, a base and an opening to define a storage volume; and - a flange formed on the container body and configured to receive a connecting element of a lid (preferably hinged) equipped with a tamper-evident mechanism.

The container may also have an active insert and/or any combination of the properties mentioned above.

In particular, the flange preferably has a horizontal portion extending outwardly from the side wall of the container body and substantially perpendicular to the side wall of the container body. A container body with such an advantageous flange can preferably maintain and attach the connection element of the lid avoiding any non-perpendicular movement of the connection element relative to the container body. Compared to a flange with an inclined upper surface, it allows reducing the risk of the connecting element slipping or detaching from the flange, for example when a vertical pressure is applied to the lid. When the cover is hinged, the horizontal part of the flange Another advantage is that due to the vertical immobility of the connecting elements of the lid (with respect to the horizontal upper and lower surfaces of the flange), the axis of rotation of the hinge also remains vertically immobile and the hinged lid can pivot along a well-defined axis of rotation In turn, it allows accurate positioning of the sealing surface of the lid relative to the wall of the container body and then allows a better airtight seal between the lid and the container body.

Preferably, the thickness of the horizontal portion of the flange is less than the thickness of the side wall of the container body taken in the area adjacent to the horizontal portion. More preferably, the ratio between the thickness of the horizontal portion of the flange and the thickness of the side wall of the container body taken in the area adjacent to the horizontal portion is less than or equal to 2/3. This favorable ratio allows avoiding defects and sink marks on the inner surface of the side wall of the container body to face the flange on the opposite surface of the side wall of the container. For example, such defects can be detrimental to the airtight seal between the lid and the inside of the container body.

100: container

102: container body

103: Horizontal part

104: Flange

105: vertical part

106: active insert

108: Storage volume

118: Peripheral pocket

150: accumulation area

202: side wall

204: base

206: opening

300: container

310: hinged cover

312: Connecting elements

314: cover part

315: sealing side edge

318: Raised

321: protrusion

323: protrusion

325: Groove

412: hinge

414: Anti-tamper mechanism/fragile link

512: Gripping part

514: Dimple part

602: side wall

604: base

700: container

702: container body

704: Flange

706: active insert

800: container

802: container body

803: Horizontal part

806: active insert

900: sealed packaging

904: packet

906: tank

908: Molded objects

B: area

S1: Outer surface

S2: inner surface

S3: Horizontal upper surface

S4: Outer surface

S5: vertical cylindrical surface

T1: Thickness

T2: Thickness

1 to 2 show a perspective view and a cross-sectional view, respectively, of an example of a container according to the invention.

FIG. 3 shows an enlarged cross-sectional view of area B of FIG. 2 .

Figures 4-5 show a cross-sectional view and a front view of a container equipped with a hinged lid.

FIG. 6 shows a cross-sectional view along plane A-A of FIG. 4 .

Figure 7 shows an enlarged cross-sectional view of a container according to another embodiment including a lid.

Fig. 8 shows an enlarged cross-sectional view of a container according to another mode with another example of a flange.

Figure 9 shows a sealed package comprising at least one container according to the invention.

1-3 show a container 100 without a lid. The container 100 includes a plastic container body 102 having a storage volume 108, a flange 104 formed on the container body 102 and mounted on the container body 102. An active insert 106 within the body 102 .

FIGS. 4-6 show a container 300 consisting of the container 100 of FIGS. 1-3 and a hinged lid 310 fitted to the container body 102 . Hinged lid 310 includes an annular connection element 312 attached to flange 104 , a lid portion 314 , and a hinge 412 connecting lid portion 314 to annular element 312 .

The container can be obtained by molding the container body 102 , preferably by injection, followed by, for example, fitting the active insert 106 inside the container body 102 . The active insert 106 can be installed within the container body 102 , for example, by pushing the active insert 106 down into the container body 102 .

The process may then continue with filling the container 100 with medical and/or pharmaceutical products. Filling may include filling the container 100 with medical and/or pharmaceutical products and joining the hinged lid 310 to the container body 102 to obtain a moisture-proof container 300 . Assembly may be performed by conveying a cap onto a container body and then applying a downward vertical force to the cap so that the cap's annular connection member snaps onto the container body's flange.

The presence of the active insert 106 within the container body 102 allows the use of a hinged lid that exhibits a smaller volume and lighter weight than a hinged lid with a drying chamber. In particular, hinged lid 310 does not contain any drying chamber and/or any active agent.

The presence of the active insert 106 inside the container body 102 also reduces the risk of active agent leakage compared to previously designed solutions in which a lid comprising a chamber filled with dehydrating agent is used. In fact, drying chambers of previous designs are generally closed by a cardboard disc that can be loosely fixed (for example, defects can occur during fastening by clamping the ends of the drying chamber), the cardboard disc can be moved from its original position or it will be in the cover. Damage during handling, especially when batches are dispensed on a packaging line, during shipping, or during handling by consumers.

Additionally, the active insert 106 fits within the container body 102 and thus is closer to the sensitive components stored in the container 100 than prior containers in which the active agent is positioned in a dry chamber in the lid. Taste. In the figure, active insert 106 surrounds the articles. In other words, the active insert defines at least a part of the storage volume. This proximity improves active function.

Referring to Figure 1, the container body 102 has a generally cylindrical shape and the flange 104 is peripheral and continuous. The flange 104 is formed on the entire periphery of the container body 102 . This allows simple manufacture and effective retention of the cover when fitted on the flange.

Referring to FIGS. 2-3 , the container body 102 includes a side wall 202 , a base 204 and an opening 206 to define a storage volume 108 .

The container body 102 further has a flange 104 including a horizontal portion 103 vertically extending from the outer surface S1 of the side wall 202 of the container body 102 . Portion 103 forms a ring on container body 102 . Section 103 includes a horizontal upper surface S3. This surface S3 prevents the risk of downward displacement of the annular connection element 312 of the hinged cover 310 .

Indeed, on prior art flanges comprising an inclined upper surface, when a strong vertical pressure is applied to the hinged cover 310, the annular connecting element can slide or even disengage from the flange. Thus, the hinged cover has the advantage of being securely attached to the flange.

Again, if the lid is well maintained on the flange, the axis of rotation of the hinge 412 remains fixed and well defined. Thus, the hinged lid can pivot along a fixed and well-defined axis of rotation, which allows the sealing surfaces to be positioned correctly and complement each other when closing the hinged lid 310 and thus guarantees a good airtightness between the lid and the container body.

The flange 104 further includes a vertical portion 105 extending vertically and downwardly from the periphery of the horizontal portion 103 . Portion 105 forms a cylinder around container body 102 . Thus, the flange 104 has a cross-section in the form of an angle, here 90°. This angular shape allows particularly good retention of the hinged cover 310 on the flange.

In the figure, the corners or curves of the cross-section of the flange 104 are rounded. In other words, the angular shape The outer edges meet slightly and a radius exists between the upper surface of the horizontal portion 103 and the outer surface of the vertical portion 105 . This also makes snapping easier (guiding the hinged lid 310 and fully re-centering it around the flange 104 when fitting the hinged lid 310 on the container body 102) and reducing the amount of time required to assemble the hinged lid 310 on the container body 102. required downward pressure.

Other embodiments are also possible. For example, the corner shape of the cross-section of the flange 104 may be chamfered or may form a right angle. In the second case, this increases the horizontal upper surface of the horizontal portion 103 and thus further improves the stability or retention of the hinged cover on the flange.

The horizontal portion 103 has a thickness T1 which is smaller than the thickness of the side wall 202 of the container body 102 in the area adjacent to the flange. This means that the thickness T1 of the horizontal portion 103 is smaller than the thickness T2 of the side wall 202 of the container body 102 at the position where the flange 104 is formed on the side wall 202 . More specifically, as depicted in the figure, the T1/T2 ratio is less than or equal to 2/3 and preferably less than 1/2. This range of relative values can reduce the risk of shrinkage (or due to an accumulation area 150 of plastic material at the junction of the flanges on the side walls and surface defects due to shrinkage of this material during cooling), while having a sufficient Durable flange 104 . This relative thickness of the horizontal portion 103 thus allows a better quality of the inner surface of the container body 102, which can have a decisive influence on the quality of the airtightness of the container.

Referring to FIGS. 6-8 , the cover portion 314 includes a sealing skirt 315 having a protrusion 318 . Additionally, the inner surface of the container body 102 includes a peripheral recess 118 . When the lid closes the opening of the container body, the protrusion 318 formed on the sealing side edge 315 cooperates with the peripheral recess 118 of the side wall 202 of the container body 102 to form an airtight seal. In this way, the storage volume 108 is insulated from the atmosphere outside the container.

The inner surface S2 of the sidewall 202 of the container body 102 is configured to retain the active insert 106 within the container body 102 . For example, the active insert can be held by clamping (tightening).

In FIG. 7 , container 700 includes a container body 702 and an active insert 706 . Connector The member includes on its inner surface protrusions 321 and 323 intended to receive and secure the flange 704 of the container body 702. The connecting element of the lid comprises on its inner surface a groove 325 (formed between protrusions 321 and 323 ) intended to cooperate with the flange of the container body. The lid 310 further includes a sealing lip that includes a protrusion 318 that cooperates with a peripheral recess 118 on the inner surface of the side wall 202 of the container body 702 .

The connecting element of the cap comprises on its inner surface a vertical cylindrical surface S5 which cooperates with the surface S4 of the vertical part of the flange once the cap is fitted on the container body. Preferably, the diameter of the vertical cylindrical surface S5 of the connection element is smaller than the outer diameter of the vertical portion of the flange before the lid is assembled to the container body. The connecting element of the lid is made of an elastic material that allows the diameter of the vertical cylindrical wall of the connecting element to expand during assembly on the container body. In this way and after fitting the lid on the container body, the connecting element of the lid exerts pressure on the vertical surface S4 of the flange to limit the rotation of the lid around the container body, especially with the lid open.

FIG. 8 shows a container body 802 in which the flange has only a horizontal portion 803 . This horizontal portion 803 is positioned at the upper end of the side wall of the container body, but could be positioned on another portion of the side wall close to the opening of the container body. The horizontal member 803 comprises a horizontal upper surface S3 whose outer end is rounded to facilitate fitting of the cover on the flange.

Referring to FIGS. 4-6 , the hinged lid 310 includes a tamper-evident mechanism including a frangible link (or bridge) 414 connecting the lid portion 314 to the annular connecting member 312 . Breaking the breakable link 414 when the hinged lid 310 is first opened, the breakable link 414 is then visible to the consumer.

The hinged lid 310 also has an opening member that includes a grip portion 512 formed in the lid portion 314 and a pocket portion 514 formed in the lid portion 314 and/or the ring member 312 . This opening member is ergonomic. Such a cover can be injection molded, for example, using a slide mold.

Figure 9 shows a sealed package 900 comprising a plurality of containers 100 according to the invention. seal Package 900 may be, for example, a hermetic capsule whose walls include an aluminum layer. Package 900 is hermetically sealed and substantially impermeable to air and, in particular, moisture and oxygen.

The package further comprises an active agent, more specifically a moisture releasing substance 902 (not shown in the figures) capable of releasing moisture within the package 900 . The moisture releasing substance 902 may be water and/or a monohydrated active agent such as, for example, silica gel, clay, a deliquescent salt, or a mixture thereof.

The moisture releasing substance may be contained in a moisture permeable pack 904 , a moisture permeable canister 906 and/or a polymer material of a molded object 908 . Instead, the molded article 908 can be made of an active material that includes a moisture releasing substance retained in a polymer matrix, such as a thermoset polymer or a thermoplastic polymer. The molded article 908 may be in any shape, such as a tablet, a sphere, a wafer or, as depicted in FIG. 9 , in the shape of a pellet comprising a composition of matter and polymer.

100: container

102: container body

104: Flange

106: active insert

118: Peripheral pocket

Claims (18)

A container (100, 300) for packaging medical and/or pharmaceutical products, wherein the container comprises: a plastic container body (102), which includes a side wall (202), a base (204) and an opening (206 ) to define a storage volume (108); a cover (310), which includes a cover portion (314) configured to close the opening of the container body (102), a connecting element (312) and a and a tamper-evident mechanism (414) between the connecting element, wherein the container includes a flange (104) formed on the container body (102) and configured to receive the lid (310) connecting element (312) so that the lid is fixed vertically on the flange, the connecting element (312) is made of an elastic material and exerts pressure on the flange when the lid is fitted on the container body on, wherein the container further comprises an active insert (106), which is placed within the container body (102), wherein the lid (310) is configured to cooperate with the side wall (202) of the container body (102) To form an airtight seal, wherein the container has a moisture permeability of less than 220mg.mm/m2.day at 40°C and 75% relative humidity. The container of claim 1, wherein the active insert (106) is formed from a material comprising a polymer and capable of interacting with one or more gaseous species of moisture, oxygen and/or a volatile organic compound at least one active agent. The container according to claim 1 or 2, wherein the flange (104) has a portion (103) extending outward from the side wall (202) of the container body (102), and the portion (103) is preferably substantially vertical A horizontal portion (103) of the side wall (202) of the container body (102). The container of claim 3, wherein the thickness of the horizontal portion (103) of the flange (104) is smaller than the thickness of the side wall (202) of the container body (102), and the thickness of the side wall is adjacent to the horizontal portion Obtained on the area of (103). The container as claimed in claim 3, wherein the thickness of the horizontal portion (103) of the flange (104) and the side wall of the container body (102) obtained on the region (150) adjacent to the horizontal portion (103) The ratio between the thicknesses of (202) is less than or equal to 2/3. The container according to claim 3, wherein the flange (104) further comprises a vertical portion (105) vertically extending from the end of the horizontal portion (103) of the flange (104). The container of claim 6, wherein the flange (104) has an angular cross-section at an angle of 90°. The container according to claim 1 or 2, wherein the flange (104) is a peripheral flange. The container according to claim 3, wherein the horizontal upper surface (S3) of the horizontal portion (103) includes a rounded or chamfered outer end. The container of claim 1 or 2, wherein the lid is a hinged lid having a hinge (412) connecting the lid portion (314) to the connecting element (312). The container according to claim 1 or 2, which has a moisture vapor permeability of less than 1 mg/day at 40° C. and 75% relative humidity. The container according to claim 1 or 2, which has a moisture vapor permeability of less than 10 μg/day/mm seal length at 40°C and 75% relative humidity. A sealed package comprising at least one container according to any one of claims 1 to 9, the package is substantially impermeable to moisture and/or oxygen. The sealed package according to claim 13, which further contains a substance capable of releasing moisture in the sealed package. The sealed package of claim 14, wherein the substance is capable of equilibrating relative humidity within the package at a substantially constant level of at least 2% rH at 20°C. The sealed package according to claim 14 or 15, wherein the substance is a hydration active agent preferably selected from silica gel, clay, deliquescent salt or a mixture thereof. A method of manufacturing a container according to any one of claims 1 to 12, comprising: supplying a container comprising an active insert placed within a container body (102) (106), the container body (102) has a flange (104) configured to receive a connecting element (312) of a lid (310) having a tamper-evident mechanism (414); filling the container body (102) with or pharmaceutical product; and assembling the cap (310) to the container body (102). A container according to any one of claims 1 to 12 is used for packaging medical and/or pharmaceutical products.

Images